An Appropriate Use of Accelerated Approval — Aducanumab for Alzheimer’s Disease
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An Appropriate Use of Accelerated Approval The FDA decision to grant accelerated approval to aducanumab for Alzheimer’s disease fits squarely in the accelerated approval pathway, which was created ...
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The FDA granted accelerated approval to aducanumab and stated that reduction of amyloid is reasonably likely to predict clinical benefit.
“The FDA has controversially granted accelerated approval to aducanumab and has opined that the reduction of amyloid is reasonably likely to predict clinical benefit 7,9,[98][99][100][101][102][103][104][105][106][107] .”
From The amyloid hypothesis in Alzheimer disease: new insights from new therapeutics (2022) · cites this paper as [102]
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“Nonetheless, as of now, a new drug, aducanumab, has obtained accelerated approval [11].”
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Additional file 1 of The therapeutic landscape of tauopathies: challenges and prospects
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- Authors
- Dunn, B., Stein, P., Temple, R., & Cavazzoni, P.
- Affiliations
- United States Food and Drug Administration (US)
- ORCID
- Dunn, Billy
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-08-26
- Volume
- 385
- Issue
- 9
- Pages
- 856-857
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3185318240
- Cited by
- 42
- References
- 2
- Citations by year
- 2026: 1 · 2025: 7 · 2024: 4 · 2023: 11 · 2022: 15 · 2021: 4
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Keywords
- aducanumab, Alzheimer's disease, accelerated approval, FDA regulatory decision, drug approval pathways, anti-amyloid therapy
- MeSH terms
- Alzheimer Disease, Humans, Amyloid beta-Peptides, Antibodies, Monoclonal, Humanized
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